TheraRadar
Data updated: May 26, 2026

RIVFLOZA (nedosiran sodium)

First-in-Class Orphan Drug Breakthrough Therapy
Rare Disease Approved 2023-09-29

Rivfloza (nedosiran) is indicated to lower urinary oxalate levels in adults and pediatric patients aged 2 years and older with primary hyperoxaluria type 1 (PH1) who have relatively preserved kidney function (eGFR ≥30 mL/min/1.73 m²). The medication reduces the systemic oxalate burden by targeting the metabolic overproduction of oxalate within the liver.

Source: FDA Label • Novo Nordisk
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How RIVFLOZA Works

Nedosiran is a double-stranded small interfering RNA (siRNA) conjugated to GalNAc aminosugar residues. This delivery system targets asialoglycoprotein receptors (ASGPR) to facilitate uptake into hepatocytes. Once inside the cell, nedosiran induces RNA interference to degrade *LDHA* messenger RNA (mRNA).

Source: FDA Label
2
Indications
--
Phase 3 Trials
2
Years on Market

Details

Status
Prescription
First Approved
2023-09-29
Patent Cliff
2038

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Patent cliff and revenue data

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Routes
INJECTION
Dosage Forms
SOLUTION

Companies

Novo Nordisk
Active Ingredient: NEDOSIRAN SODIUM

RIVFLOZA Approval History

2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2023 to 2025 · 1 indication expansions
Mar 2025 SUPPL
Efficacy
FDA Letter Label
Sep 2023 ORIGINAL
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What RIVFLOZA Treats

1 indications

RIVFLOZA is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Primary Hyperoxaluria Type 1
Source: FDA Label

RIVFLOZA Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

1

Same indication, different mechanism — what else might this patient receive?

OXLUMO
ALNYLAM PHARMS
2020 1 indic.

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to RIVFLOZA

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

OXLUMO
LUMASIRAN SODIUM
1 shared
ALNYLAM PHARMS INC
Shared indications:
Primary Hyperoxaluria Type 1
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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

RIVFLOZA FDA Label Details

Indications & Usage

FDA Label (PDF)

RIVFLOZA is indicated for the treatment of Primary Hyperoxaluria Type 1.

View full patent landscape →
6 OB patents · 2 families · 68 international docs across 18 countries

RIVFLOZA Patents & Exclusivity

Latest Patent: Oct 2038
Exclusivity: Sep 2030

Patents (6 active)

US11661604 Expires Oct 12, 2038
US11286488 Expires Oct 12, 2038
US11053502 Expires Oct 29, 2035
US11359203 Expires Oct 9, 2035
US10738311 Expires Oct 9, 2035
US10351854 Expires Oct 9, 2035

Exclusivity

NCE Until Sep 2028
NPP Until Mar 2028
ODE-443 Until Sep 2030
NCE Until Sep 2028
NPP Until Mar 2028
ODE-443 Until Sep 2030
NCE Until Sep 2028
NPP Until Mar 2028
ODE-443 Until Sep 2030
NCE Until Sep 2028
NPP Until Mar 2028
ODE-443 Until Sep 2030
NCE Until Sep 2028
NPP Until Mar 2028
ODE-443 Until Sep 2030
NCE Until Sep 2028
NPP Until Mar 2028
ODE-443 Until Sep 2030
NCE Until Sep 2028
NPP Until Mar 2028
ODE-443 Until Sep 2030
NCE Until Sep 2028
NPP Until Mar 2028
ODE-443 Until Sep 2030
NCE Until Sep 2028
NPP Until Mar 2028
ODE-443 Until Sep 2030
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2038
  • • 54 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • 1 similar drugs
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA215842 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.